BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7056209 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-08034
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    January 1, 2015
    Report Date
    March 8, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION/ PERFORATION (FALLOPIAN TUBES)"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND DEVICE EXPULSION ("MIGRATION OF IMPLANT/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 781803) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED NAUSEA, VOMITING, AMNIOTIC FLUID LEAKAGE AND STOMACH PAIN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"). IN 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). IN 2013, THE PATIENT EXPERIENCED BACTERIAL INFECTION ("BACTERIAL INFECTIONS"). IN 2015, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2016, 6 YEARS 3 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED CHOLELITHIASIS ("GALLSTONES"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT,HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL REMOVALOF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, DEVICE EXPULSION, DYSPAREUNIA, ABDOMINAL PAIN, BACK PAIN AND CHOLELITHIASIS OUTCOME WAS UNKNOWN AND THE BACTERIAL INFECTION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BACTERIAL INFECTION, CHOLELITHIASIS, DEVICE BREAKAGE, DEVICE EXPULSION, DYSPAREUNIA AND FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT CT SCAN AND IT SHOWED THE SPRING OPEN. HE TOLD ME IT HAD MOVED FROM MY FALLOPIAN TUBE INTO MY UTERUS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUN-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. EVENT ADDED: BACTERIAL INFECTIONS, DEVICE BREAKAGE, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), SEVERE ABDOMINAL PAIN, BACK PAIN, GALLSTONES. CONCOMITANT CONDITIONS WERE ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION/ PERFORATION (FALLOPIAN TUBES)"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND DEVICE EXPULSION ("MIGRATION OF IMPLANT/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 781803-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED NAUSEA, VOMITING, AMNIOTIC FLUID LEAKAGE AND STOMACH PAIN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"). IN 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). IN 2013, THE PATIENT EXPERIENCED BACTERIAL INFECTION ("BACTERIAL INFECTIONS"). IN 2015, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2016, 6 YEARS 3 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED CHOLELITHIASIS ("GALLSTONES"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT,HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)), SURGERY (TO REMOVE THE ESSURE IMPLANT,HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)) AND SURGERY (TO REMOVE THE ESSURE IMPLANT,HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, DEVICE EXPULSION, DYSPAREUNIA, ABDOMINAL PAIN, BACK PAIN AND CHOLELITHIASIS OUTCOME WAS UNKNOWN AND THE BACTERIAL INFECTION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BACTERIAL INFECTION, CHOLELITHIASIS, DEVICE BREAKAGE, DEVICE EXPULSION, DYSPAREUNIA AND FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT CT SCAN AND IT SHOWED THE SPRING OPEN. HE TOLD ME IT HAD MOVED FROM MY FALLOPIAN TUBE INTO MY UTERUS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED: EVENT DEVICE MONITORING PROCEDURE NOT PERFORMED ADDED. INCIDENT. NO VALID LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION/ PERFORATION (FALLOPIAN TUBES)"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND DEVICE EXPULSION ("MIGRATION OF IMPLANT/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 781803-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED NAUSEA, VOMITING, AMNIOTIC FLUID LEAKAGE AND STOMACH PAIN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). IN 2013, THE PATIENT EXPERIENCED BACTERIAL INFECTION ("BACTERIAL INFECTIONS"). IN 2015, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2016, 6 YEARS 3 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED CHOLELITHIASIS ("GALLSTONES"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)), SURGERY (TO REMOVE THE ESSURE IMPLANT, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)) AND SURGERY (TO REMOVE THE ESSURE IMPLANT, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, DEVICE EXPULSION, DYSPAREUNIA, ABDOMINAL PAIN, BACK PAIN AND CHOLELITHIASIS OUTCOME WAS UNKNOWN AND THE BACTERIAL INFECTION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BACTERIAL INFECTION, CHOLELITHIASIS, DEVICE BREAKAGE, DEVICE EXPULSION, DYSPAREUNIA AND FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT CT SCAN AND IT SHOWED THE SPRING OPEN. HE TOLD ME IT HAD MOVED FROM MY FALLOPIAN TUBE INTO MY UTERUS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-AUG-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: NO VALID LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION/ PERFORATION (FALLOPIAN TUBES)"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND DEVICE EXPULSION ("MIGRATION OF IMPLANT/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 781803-INV, 731803) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED NAUSEA, VOMITING, AMNIOTIC FLUID LEAKAGE AND STOMACH PAIN. ON (B)(6)2010, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"). IN 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). IN 2013, THE PATIENT EXPERIENCED BACTERIAL INFECTION ("BACTERIAL INFECTIONS"). IN 2015, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6)2016, THE PATIENT EXPERIENCED CHOLELITHIASIS ("GALLSTONES"), 6 YEARS 3 MONTHS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT,HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, DEVICE EXPULSION, DYSPAREUNIA, ABDOMINAL PAIN, BACK PAIN AND CHOLELITHIASIS OUTCOME WAS UNKNOWN AND THE BACTERIAL INFECTION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BACTERIAL INFECTION, CHOLELITHIASIS, DEVICE BREAKAGE, DEVICE EXPULSION, DYSPAREUNIA AND FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT CT SCAN AND IT SHOWED THE SPRING OPEN. HE TOLD ME IT HAD MOVED FROM MY FALLOPIAN TUBE INTO MY UTERUS. DISCREPANCY NOTED IN ESSURE IMPLANT AND EXPLANT DATE: DATE(S) OF INSERTION: (B)(6)2010 DATE(S) OF REMOVAL: (B)(6)2015- TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED) QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-MAR-2019: PFS RECEIVED. LOT NUMBER ADDED. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT") AND PERFORATION ("PERFORATION") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PERFORATION AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, PELVIC PAIN AND PERFORATION TO BE RELATED TO ESSURE. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834491 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 781803-INV, 731803

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R